Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
168145–168168 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 11, 1980
SEARLE PHO/SONIC ALPHA 2000
K800139 · IYO
G.D. Searle and Co.
Radiology · 21d
Cleared Feb 11, 1980
ONCE TM
K800162 · HDW
G.D. Searle and Co.
Obstetrics & Gynecology · 17d
Cleared Feb 11, 1980
I.M. BLADES
K800177 · GDX
Instrument Makar, Inc.
General & Plastic Surgery · 14d
Cleared Feb 11, 1980
INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR
K800179 · DXW
Sphygmetrics, Inc.
Cardiovascular · 13d
Cleared Feb 11, 1980
OXFORD EXTERNAL FIXATION SYSTEM
K800184 · JEC
Downs Surgical , Ltd.
Orthopedic · 13d
Cleared Feb 11, 1980
OVALITH P-BP BIPOLAR CARDIAC PACEMAKER
K800194 · DXY
Coratomic, Inc.
Cardiovascular · 13d
Cleared Feb 11, 1980
COTTON UNDER CAST PADDING
K800195 · ITG
Winn Hirsch & Assoc.
Physical Medicine · 13d
Cleared Feb 11, 1980
UHR UNIVERSAL6HIP REPLACEMENT
K800207 · KWL
Osteonics Corp.
Orthopedic · 12d
Cleared Feb 08, 1980
DEXIDE DISPOSABLE PREP STICK W/IODOPHOR
K792270
Dexide, Inc.
General Hospital · 87d
Cleared Feb 07, 1980
ANESTHESIA & HOSPITAL SYRINGE HOLDER
K792520 · FMF
Medical Innovations Corp.
General Hospital · 63d
Cleared Feb 06, 1980
CONTINUOUS AMBULATORY DIALYSIS (CAPD)
K791512 · KDJ
Norton Performance Plastics Corp.
Gastroenterology & Urology · 201d
Cleared Feb 06, 1980
RECTAL LEAKAGE INHIBITOR
K792597 · KNT
Augustin Jones, M.D.
Gastroenterology & Urology · 51d
Cleared Feb 06, 1980
GAMBRO LUNDIA PLATE DIALYZER
K792611 · FJG
Gambro, Inc.
Gastroenterology & Urology · 50d
Cleared Feb 06, 1980
UNILAB CULTURING SET
K792648 · FRC
Sybron Corp.
General Hospital · 47d
Cleared Feb 06, 1980
CAPD TRANSFER SET JC9044
K792651 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 47d
Cleared Feb 06, 1980
ROYCO MODEL 951 CELL MIXER
K800104 · KSQ
Royco Instruments
Hematology · 21d
Cleared Feb 06, 1980
X-FLO
K800110 · HQE
Contemporary Surgical Systems, Inc.
Ophthalmic · 21d
Cleared Feb 06, 1980
EXTEMP/EXTEMP-V
K800153 · GAA
Pharma-Filter, Inc.
General & Plastic Surgery · 14d
Cleared Feb 06, 1980
TONGUE HOLDER/SALIVA EJECTOR
K800210 · DYN
Unitek Corp.
Dental · 5d
Cleared Feb 05, 1980
WRIGHT DOW CORNING SOFTGOODS W/DOW
K792269 · IPY
Dow Corning Wright
Physical Medicine · 88d
Cleared Feb 05, 1980
SHARPLAN 743, CO2 LASER SURGICAL SYSTEM
K792418 · GEX
Laser Industries , Ltd.
General & Plastic Surgery · 70d
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792451 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC RESUSCITATOR INSTANT ACTION SET
K792452 · DRM
Pneupac , Ltd.
Cardiovascular · 64d
Cleared Feb 05, 1980
PNEUPAC OXYGEN THERAPY UNIT
K792453 · BTL
Pneupac , Ltd.
Anesthesiology · 64d